[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-174221-en":3,"doc-seo-174221-105":30,"detail-sidebar-cat-1-en-105":92},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":11,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":29},174221,13056703019662,"Evangeline","https://ap-avatar.wpscdn.com/avatar/be000253a8e92610077?_k=1778726343310543188",1,18,"Letters","Investigator Manual - Investigator Manual","Investigator Manual (Effective April 7, 2023) provides practical guidance for researchers working with the USF Institutional Review Board. It explains the purpose of the manual, key concepts in human subjects research, and the Human Research Protection Program, then details required staff training and investigator financial disclosure. The manual covers submission steps, review responsibilities, single-IRB and external-IRB use, protocol development, consent and documentation, modifications and reconsent, reporting obligations, and post-approval duties including record keeping and adverse event submission.","Investigator Manual\nEffective April 7, 2023\nUSF Institutional Review Board\n\u0013 HYPERLINK \"https://www.usf.edu/research-innovation/research-integrity-compliance/documents/dric-map.pdf\" \u0014Research Integrity & Compliance\n3702 Spectrum Blvd, Suite 165 MDC35\nTampa, Florida 33612\u0015\nEmail: \u0013 HYPERLINK \"mailto:RSCH-IRB@usf.edu\" \u0014RSCH-IRB@usf.edu\u0015\nPhone: 813-974-5638\nARC Help Desk: \u0013 HYPERLINK \"mailto:RSCH-ARC@usf.edu\" \u0014RSCH-ARC@usf.edu\u0015\nTable of Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc131679872\" \u00141.\tWhat is the purpose of this manual?\t\u0013 PAGEREF _Toc131679872 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679873\" \u00142.\tWhat is human subjects research?\t\u0013 PAGEREF _Toc131679873 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679874\" \u00143.\tWhat is the Human Research Protection Program?\t\u0013 PAGEREF _Toc131679874 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679875\" \u00144.\tWhat training do my staff and I need to conduct human subjects research?\t\u0013 PAGEREF _Toc131679875 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679876\" \u00145.\tWhat financial interests do my staff and I need to disclose to the USF IRB?\t\u0013 PAGEREF _Toc131679876 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679877\" \u00146.\tHow do I submit new human subjects research to the IRB?\t\u0013 PAGEREF _Toc131679877 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679878\" \u00147.\tWho needs to review my research before I submit it to the IRB?\t\u0013 PAGEREF _Toc131679878 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679879\" \u00148.\tHow do I request to use an external IRB?\t\u0013 PAGEREF _Toc131679879 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679880\" \u00149.\tHow do I request the USF IRB to serve as the single IRB (sIRB) of record for my collaborative or multi-site research study?\t\u0013 PAGEREF _Toc131679880 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679881\" \u001410.\tHow do I transfer IRB Oversight?\t\u0013 PAGEREF _Toc131679881 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679882\" \u001411.\tHow do I write an Investigator Protocol?\t\u0013 PAGEREF _Toc131679882 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679883\" \u001412.\tHow do I submit an application for a Coordinating or Data Coordinating Center?\t\u0013 PAGEREF _Toc131679883 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679884\" \u001413.\tDo case reports or limited case series need to be submitted to the IRB?\t\u0013 PAGEREF _Toc131679884 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679885\" \u001414.\tDo I need a data and safety monitoring plan (DSMP)?\t\u0013 PAGEREF _Toc131679885 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679886\" \u001415.\tWhat if I am doing my research at a non-USF (or non-affiliate) location?\t\u0013 PAGEREF _Toc131679886 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679887\" \u001416.\tWhat if I am doing my research outside of the country?\t\u0013 PAGEREF _Toc131679887 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679888\" \u001417.\tAre there any Florida Laws that I should be aware of that might affect my research plan?\t\u0013 PAGEREF _Toc131679888 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679889\" \u001418.\tWhat if I want to conduct research in schools or obtain student records?\t\u0013 PAGEREF _Toc131679889 \\h \u001422\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679890\" \u001419.\tWhat if I want to include deception in my research?\t\u0013 PAGEREF _Toc131679890 \\h \u001424\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679891\" \u001420.\tHow do I create a consent document?\t\u0013 PAGEREF _Toc131679891 \\h \u001425\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679892\" \u001421.\tDo I need to include injury language in my consent?\t\u0013 PAGEREF _Toc131679892 \\h \u001426\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679893\" \u001422.\tCan I compensate subjects for their participation?\t\u0013 PAGEREF _Toc131679893 \\h \u001427\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679894\" \u001423.\tWhat are the different regulatory classifications that research activities may fall under?\t\u0013 PAGEREF _Toc131679894 \\h \u001428\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679895\" \u001424.\tWhat are the decisions the IRB can make when reviewing proposed research?\t\u0013 PAGEREF _Toc131679895 \\h \u001428\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679896\" \u001425.\tHow does the IRB decide whether to approve human subjects research?\t\u0013 PAGEREF _Toc131679896 \\h \u001429\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679897\" \u001426.\tWhat will happen after IRB review?\t\u0013 PAGEREF _Toc131679897 \\h \u001429\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679898\" \u001427.\tWhat are my obligations after USF IRB approval?\t\u0013 PAGEREF _Toc131679898 \\h \u001430\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc131679899\" \u001428.\tWhat are some examples o","cbCaidVxwrk8WdDo","https://ap.wps.com/l/cbCaidVxwrk8WdDo","docx",414890,96,"English","en",105,"# What is the purpose of this manual?\n# What is human subjects research?\n# What is the Human Research Protection Program?\n# What training do my staff and I need to conduct human subjects research?\n# What financial interests do my staff and I need to disclose to the USF IRB?\n# How do I submit new human subjects research to the IRB?\n# How do I write an Investigator Protocol?\n# How do I create a consent document?\n# What will happen after IRB review?\n# What are my obligations after USF IRB approval?","[{\"question\":\"What is the purpose of this Investigator Manual?\",\"answer\":\"It defines how investigators should engage with the USF Institutional Review Board and the Human Research Protection Program for human subjects research.\"},{\"question\":\"What training and disclosures are required for investigators and staff?\",\"answer\":\"The manual addresses required training for conducting human subjects research and describes financial interests that must be disclosed to the USF IRB.\"},{\"question\":\"How are new studies submitted and what happens after IRB review?\",\"answer\":\"It outlines how to submit new research to the IRB and describes the process following review, including investigator obligations after approval.\"}]","Investigator Manual - Investigator Manual | 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